The United States federal government should disallow AI Inventorship in the case of patents for essential medicines.

Redefining standards of patentability and patentable subject matter, to leave essential medicines enabled by AI outside the scope of the patent system will increase access by ensuring a competitive market, which will drive prices down. In this model, non-essential medicines will still be entitled to patent protection, provided that the invention satisfies existing requirements for patent eligibility. Innovating companies will similarly be entitled to patent protection if they can demonstrate that their R&D processes do not rely on AI systems. The reform will be accompanied by a ten-year transition period where an otherwise ineligible essential medicine will be entitled to patent protection if (i) documentation from the FDA shows it to be more effective than alternative products in the market, or (ii) if the innovating company demonstrates the associated R&D costs to be considerably higher than industry average. The first exception will aid in directing R&D efforts to inventions with potential for more social value. Under the second exception, innovating companies investing heavily in their R&D processes, such as those developing in-house AI systems, will be entitled to patent protection for both essential and non-essential medicines. Through these exceptions, the new system will retain some of the incentives available under the current regime for a period of ten years. This transition period will allow for observation of the new system and for adjustment of its application if necessary.